LeprosyLAST•BrNCT06761469
Leprosy Active Searching Trial in Brazil
A study testing Implementing active-case finding strategies in people with Leprosy, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- Implementing active-case finding strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Municipalities
- Municipality recognized by the Brazilian Institute of Geography and Statistics as part of the Brazilian Federation.
- Municipality with operational epidemiological classification by the Ministry of Health (BMoH) as: 'municipalities with cases in the period from 2015 to 2019'.
- Municipality with authorization/consent from the government to participate in the study.
- Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.
- Participants
- Patients with positive Leprosy Suspicion Questionnaire (LSQ): children under five years old with Free and Informed Consent Form (ICF) signed by parents/guardians, 5-17 years old with ICF signed by parents/guardians and Free and Informed Assent Form (IAF) signed by the minor, and patients over 18 years old with ICF signed for: rapid test collection, comorbidity questionnaire and clinical evaluation; and if leprosy diagnosis is confirmed, collection of complementary exams.
Who cannot join
- Municipalities
- Municipality with extreme population size (municipalities with a number of inhabitants lower than the 10th percentile and higher than the 90th percentile).
- Municipality with operational epidemiological classification by the BMoH as: 'municipalities without cases in the period 2015 to 2019'.
- Municipalities with active or recent participation (less than one year) in other active-finding strategies, in addition to the usual ones: ministerial, Non-Governmental Organizations (NGOs), academic, among others.
- Primary Health Units
- UBS with limited multidisciplinary team (absence of physicians, nurse and/or community health agents).
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- UBS with difficult access (no access by land, i.e. riverside populations).
- UBS with territorial coverage exclusively of indigenous populations.
- Participants
- LSQ negative.
- Patients with a previous diagnosis or history of treated leprosy.
- Patients residing/registered outside the selected municipality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil
The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are:
- Does the intervention increase the number of new leprosy cases detected compared to standard care?
Read more
Participants will:
- Receive community awareness about leprosy.
- Be screened using the Leprosy Suspicion Questionnaire at priority areas identified by georeference tools.
- Undergo clinical evaluation by a trained medical team.
- If leprosy is diagnosed, affected patients will collect complementary laboratory exams
Healthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of patients who have been diagnosed.
- Conditions
- Leprosy
- Being tested
- Implementing active-case finding strategies
- Keywords
- Leprosy, Active-case finding, Cluster stepped-wedge, Clinical trial, Brazil
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementing active-case finding strategiesOther
Implementation of a multifactorial active-case finding strategy, including: (1) raising awareness among the population about leprosy; (2) theoretical and practical educational training for healthcare workers; (3) georeferencing of historical and existing cases in the municipality (from 2012 to 2023) and of new cases diagnosed throughout the study (dynamic changes); (4) screening tools for signs/symptoms of the disease (application of Leprosy Suspicion Questionnaire); and (5) serological profile (rapid test) of patients with reported signs/symptoms (positive answers Leprosy Suspicion Questionnaire).
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted intervention | Experimental | Implementation of active-case finding strategies Receives: Other: Implementing active-case finding strategies |
| Standard of care | No intervention | Routine screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
New cases of leprosy
Number of new cases of leprosy: incidence rate of leprosy per 100,000 inhabitants.
Measured: From the date of identification of at least one positive response in the Leprosy Suspicion Questionnaire until the date of confirmation or ruling out leprosy, assessed up to 2 months.
Secondary outcomes (1)
Leprosy Suspicion Questionnaire usefulness
Estimation of the diagnostic utility of positive LSQ and positive LSQ plus rapid test
Measured: From the application date of the Leprosy Suspicion Questionnaire and the rapid test until the date of confirmation or ruling out leprosy, it is assessed for up to 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jun 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Cluster stepped-wedge
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Alemão Oswaldo Cruz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Andres Vernal Carranza, Hospital Alemão Oswaldo Cruz
- Investigators
- Rosa C Lucchetta, PhD, Study director, Hospital Alemão Oswaldo Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761469
- Sponsor's protocol ID
- 78510724.3.0000.0070
- Acronym
- LAST•Br
- Status last verified
- Apr 2026
- First submitted
- 30 Dec 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil
- ClinicalTrials.gov ID
- NCT06761469
- Acronym / sponsor ID
- LAST•Br / 78510724.3.0000.0070
- Conditions
- Leprosy
- Keywords
- Leprosy, Active-case finding, Cluster stepped-wedge, Clinical trial, Brazil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Hospital Alemão Oswaldo CruzUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are:
- Does the intervention increase the number of new leprosy cases detected compared to standard care?
Participants will:
- Receive community awareness about leprosy.
- Be screened using the Leprosy Suspicion Questionnaire at priority areas identified by georeference tools.
- Undergo clinical evaluation by a trained medical team.
- If leprosy is diagnosed, affected patients will collect complementary laboratory exams
Healthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of patients who have been diagnosed.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Multifaceted intervention | Experimental | Other: Implementing active-case finding strategiesImplementation of active-case finding strategies |
| Standard of care | No intervention | –Routine screening |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Municipalities
- Municipality recognized by the Brazilian Institute of Geography and Statistics as part of the Brazilian Federation.
- Municipality with operational epidemiological classification by the Ministry of Health (BMoH) as: 'municipalities with cases in the period from 2015 to 2019'.
- Municipality with authorization/consent from the government to participate in the study.
- Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.
Key exclusion criteria (12 listed)
- Municipalities
- Municipality with extreme population size (municipalities with a number of inhabitants lower than the 10th percentile and higher than the 90th percentile).
- Municipality with operational epidemiological classification by the BMoH as: 'municipalities without cases in the period 2015 to 2019'.
- Municipalities with active or recent participation (less than one year) in other active-finding strategies, in addition to the usual ones: ministerial, Non-Governmental Organizations (NGOs), academic, among others.
- Primary Health Units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementing active-case finding strategiesImplementation of a multifactorial active-case finding strategy, including: (1) raising awareness among the population about leprosy; (2) theoretical and practical educational training for healthcare workers; (3) georeferencing of historical and existing cases in the municipality (from 2012 to 2023) and of new cases diagnosed throughout the study (dynamic changes); (4) screening tools for signs/symptoms of the disease (application of Leprosy Suspicion Questionnaire); and (5) serological profile (rapid test) of patients with reported signs/symptoms (positive answers Leprosy Suspicion Questionnaire). | Other | Multifaceted intervention |
Primary outcome
New cases of leprosy
Time frame: From the date of identification of at least one positive response in the Leprosy Suspicion Questionnaire until the date of confirmation or ruling out leprosy, assessed up to 2 months.
Number of new cases of leprosy: incidence rate of leprosy per 100,000 inhabitants.
1 secondary outcome
Leprosy Suspicion Questionnaire usefulness
Time frame: From the application date of the Leprosy Suspicion Questionnaire and the rapid test until the date of confirmation or ruling out leprosy, it is assessed for up to 2 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa C Lucchetta, PhD study director
Hospital Alemão Oswaldo Cruz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementing active-case finding strategies in people with Leprosy, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New cases of leprosy (time frame: From the date of identification of at least one positive response in the Leprosy Suspicion Questionnaire until the date of confirmation or ruling out leprosy, assessed up to 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.